The Food and Drug Administration (FDA) recently approved alemtuzumab for the treatment of patients with chronic lymphocytic leukemia (CLL) who have failed standard chemotherapy.

Chronic lymphocytic leukemia (CLL) is a cancer involving the lymph (immune) system, which includes lymph nodes, blood, and blood vessels found throughout the body, as well as the spleen, thymus, and tonsils. This cancer is found in large amounts in circulating blood and bone marrow (spongy material inside large bones that produces blood forming cells). Chronic lymphocytic leukemia is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells, of which there are two types: B and T-cells. These cells are produced in the bone marrow and each has a very specific function in aiding the body to fight infection. The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal, accumulating in the blood, bone marrow, lymph nodes and spleen. This results in overcrowding of these areas, suppressing the formation and function of blood and immune cells that are normally present. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further decrease in the ability of the body to fight infection. Chronic lymphocytic leukemia is considered to be a slow-growing, or low-grade cancer.

Standard treatment for CLL typically consists of chemotherapy involving an alkylating agent and fludarabine. Patients who stop responding to these treatments currently have limited alternative therapies. Thus, the approval of an effective agent for CLL patients who have failed standard therapies is very encouraging.

Alemtuzumab is a type of biologic therapy called a monoclonal antibody. Monoclonal antibodies are proteins that can be made in the laboratory and are designed to recognize and bind to very specific cells. Alemtuzumab is a monoclonal antibody that binds to proteins on the surface of B and T-lymphocytes. This binding action stimulates the immune system to attack and kill the cancerous lymphocytes, sparing most healthy cells in the body from destruction. This is in contrast to chemotherapy or radiation, which does not differentiate between cancer cells and healthy cells in the body, a characteristic leading to potentially destructive side effects.

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The FDA review panel reviewed the results of a clinical study evaluating alemtuzumab. Ninety-three patients with CLL who had stopped responding to chemotherapy received alemtuzumab. Over one-third of patients achieved a complete or partial disappearance of their cancer. The response lasted for an average duration of nearly 7 months. The average survival following therapy was 16 months. In this study, alemtuzumab appeared to improve patients’ quality of life, most notably through improving negative effects caused by cancer including weight loss, fatigue, night sweats and fever. However, side effects caused by alemtuzumab, such as infection, fever, nausea and vomiting, were experienced by the majority of patients. Two previous trials evaluating alemtuzumab in CLL patients that had stopped responding to standard therapies reported response rates of 21% and 29%, with the durations of response lasting 7 months and 11 months, respectively.

Patients with CLL that has stopped responding to standard chemotherapy may wish to speak with their doctor about the risks and benefits of treatment with alemtuzumab.

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